—#215111

Product

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K242390
Affected lot / code info: UDI/DI 05413765852428, All Serial Numbers

Why it was recalled

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Baxter issued an "URGENT MEDICAL DEVICE CORRECTION" to its consignees on 08/04/2025 via USPS first class mail. The notice described the problem, hazard involved, and actions to be Taken by customers: 1. Users should rely on their clinical judgment. When providing patient care involving high risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient's treatment. 2. If an alternate pump is not available or appropriate for patient care you may continue to use the Novum IQ LVP and Novum IQ Syringe Pump consistent with the following actions: - If a blank Run screen is displayed during an infusion on the Novum IQ LVP, the user should open the door, press the tubing into load point 3, then load point 4, to turn the light green, and close the door. If a blank Run screen is displayed during an infusion on the Novum IQ Syringe Pump, the user should unload, then reload the syringe. If these actions do not resolve the blank screen, both LVP and Syringe Pump users should power-cycle the pump, select "Yes" to the new patient prompt, and reprogram the infusion. - To prevent a false motor movement system error, do not program the Novum IQ syringe pump to infuse below the Minimum Recommended Flow Rate for a syringe size of 10 mL or greater. 3. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. 4. Please forward a copy of this communication to any departments within your institution who use the affected product. 5. Print and post Attachment A in areas frequented by potential users. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US distribution including Puerto Rico and OUS (International) Canada

Timeline

Recall initiated: 2025-08-04
Posted by FDA: 2025-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.